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Sponsors and Collaborators: |
Sofradim Production Covidien |
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Information provided by: | Sofradim Production |
ClinicalTrials.gov Identifier: | NCT00827944 |
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.
Condition | Intervention | Phase |
---|---|---|
Hernia, Inguinal |
Device: Parietex Progrip Device: Low weight polypropylene mesh |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia |
Estimated Enrollment: | 600 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Parietex ProGrip
|
Device: Parietex Progrip
Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. |
2: Active Comparator
Low weight polypropylene mesh
|
Device: Low weight polypropylene mesh
Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures |
Ages Eligible for Study: | 31 Years to 74 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elodie Franchimont, Sr CRA | +33 4 74 08 78 95 | elodie.franchimont@covidien.com |
Contact: Patrice Becker, Clinical Research Director | +33 4 74 08 92 38 | patrice.becker@covidien.com |
Germany | |
Klinikum Bremen-Mitte | Recruiting |
Bremen, Germany, 28177 | |
Contact: Silke SCHÜLE, Doctor +49 421 497 3256 silke.schuele@klinikum-bremen-mitte.de | |
Principal Investigator: Silke SCHÜLE, Doctor | |
Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik | Not yet recruiting |
Fulda, Germany, D- 36039 Fulda | |
Contact: APPEL Peter, Dr +49 (661) 15 321 p.appel@herz-jesu-krankenhaus.de | |
Principal Investigator: APPEL Peter, Dr | |
Netherlands | |
Catharina-ziekenhuis | Recruiting |
Eindhoven, Netherlands, 5623 EJ | |
Contact: Loes Van den Nieuwenhof, Study Nurse +31 40 2397159 loes.biesheuvel@catharina-ziekenhuis.nl | |
Principal Investigator: Simon NIENHUIJS, Doctor | |
Sweden | |
Medical Center Linköping | Recruiting |
Linköping, Sweden, 582 24 | |
Contact: Staffan SMEDS, Professor + 46 13 376 027 staffan.smeds@medcentrum.se | |
Principal Investigator: Staffan SMEDS, Professor | |
United Kingdom | |
Derriford Hospital | Recruiting |
Plymouth, United Kingdom, PL6 | |
Contact: Maggie Gavasingha, Study Nurse + 44 1752 439295 Maggie.Gavasingha@phnt.swest.nhs.uk | |
Principal Investigator: Andrew KINGSNORTH, Professor | |
Western Infirmary | Recruiting |
Glasgow, United Kingdom, G11 6NT | |
Contact: Gwen TOMSON, secretary +44 141 211 2804 gwen.thomson@ggc.scot.nhs.uk | |
Principal Investigator: Patrick Joseph O'DWYER, Professor |
Responsible Party: | Sofradim Production ( BECKER Patrice ) |
Study ID Numbers: | SC 0607/1 |
Study First Received: | January 22, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00827944 History of Changes |
Health Authority: | Germany: Ethics Commission; Sweden: Regional Ethical Review Board; Netherlands: Medical Ethics Review Committee (METC); United Kingdom: Research Ethics Committee; United States: Institutional Review Board |
Uncomplicated primary inguinal hernias |
Pathological Conditions, Anatomical Hernia Hernia, Abdominal Hernia, Inguinal |
Pathological Conditions, Anatomical Hernia Hernia, Abdominal Hernia, Inguinal |